On March 23, 2023, the Minister of Health (the "Minister") introduced Bill 15, an Act to make the health and social services system more efficient (the "Bill").
As described in our bulletin, "Bill 15: The Quebec Government Wants to Limit the Specific Medical Necessity Measure", an essential aspect of the Bill modifies the Specific Necessity Measure by introducing additional conditions of patient eligibility.
The measure deals with the use of drugs for patients in hospital which are not listed on the List of Medications - Establishments, including, approved drugs, unauthorized drugs or the use of approved drugs for an unauthorized (off-label) indication.
Section 336 stipulates that any professional wishing to use these drugs must first obtain written authorization from the establishment's Committee of Pharmacology ("Committee").
Moreover, the government is adding an additional prerequisite for a drug to be considered eligible for a patient. In particular, it's a prerequisite to authorization that the Institut national d'excellence en santé et en services sociaux (INESSS) does not refuse to recognize the therapeutic value of the drug for the requested indication.
The Amendments Proposed by The Minister Last August
Subsequently, in August 2023, amendments were proposed to the Bill, detailed in our follow-up bulletin provide for increased flexibility: in certain very specific cases, a Committee will be able to authorize the supply of a drug that has received a negative recommendation from INESSS.
In particular, authorization to access a non-Listed drug which received a negative INESSS recommendation may be granted by the Committee if the severity of the patient's condition necessitates the drug, and if delaying treatment would lead to short-term complications, that could result in irreversible deterioration of the patient's condition, or death (the "Exception").
The severity of the condition, the speed at which it deteriorates, and the length of time it will take for new data to become available, which enables INESSS to reassess the therapeutic value of the treatment, are all factors to be taken into account when making a decision.
The Latest Amendments Adopted
On September 28, following additional pressure from patients and health professionals, the Minister revised the Exception in order to reduce the risk of overly strict applications.
The new version of the Exception provides that authorization may be granted if the patient's condition requires the drug and if delaying could likely lead to short-term complications which could likely lead to an irreversible deterioration of the patient's condition. Thus, the notion of the severity of the condition and the obligation, in short-term, to maybe cause death are completely removed from the authorization criteria.
As a result, the specific medical necessity measure may be available to patients whose particular condition is likely to lead, in the short term, to an irreversible deterioration of the patient's condition, whether or not that condition is potentially fatal.
Conclusion
The amendments adopted by the Commission reassure patients and confirm that it is not only in cases of imminent death that the specific medical necessity measure may now be authorized.
However, despite the Minister's openness, the question still remains as to how these new measures will be implemented in practice. Will these changes make the process so cumbersome as to diminish the enthusiasm of health care professionals for the specific medical necessity measure?
As the Bill is still in progress, Fasken's Life Sciences group closely monitors new developments and remains available to help industry players navigate through these changes.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
